DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands

NCT06225492 | Completed Phase 4 FDA Drug

• 1 other identifier: DAXI0823
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Effectiveness of DaxibotulinumtoxinA for platysmal neck bands measured on Platysmal Neck Banding Scale

  Platysmal Neck Banding Scale (Scored on a 0-4 scale with 4 being the most severe)

  3 months

Secondary Outcomes (1)

• Evaluate patient-reported outcomes (patient satisfaction with neck using FACE-Q scale)

  3 months

Study Arms (2)

DaxibotulinumtoxinA 20 units

EXPERIMENTAL

Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.

Drug: DaxibotulinumtoxinA 20 units

DaxibotulinumtoxinA 15 units

EXPERIMENTAL

Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.

Drug: DaxibotulinumtoxinA 15 units

Interventions

DaxibotulinumtoxinA 15 units DRUG

Subjects will be treated with 15 units of daxibotulinumtoxinA per platysmal band

Also known as: Daxxify

DaxibotulinumtoxinA 15 units

DaxibotulinumtoxinA 20 units DRUG

Subjects will be treated with 20 units of daxibotulinumtoxinA per platysmal band

Also known as: Daxxify

DaxibotulinumtoxinA 20 units

Eligibility Criteria

• Age: 31 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>30 years old
• Rating of 2, 3, or 4 on 5-point Merz Neck Scale
• No use of any botulinum toxin in the neck for the past 6 months

You may not qualify if:

• Pregnancy
• Prior adverse reaction or known hypersensitivity to neuromodulators treatment
• Connective tissue disorder
• Scar in the treatment area
• History of dysphagia and/or neuromuscular disorders (such as but not limited to Amyotrophic Lateral Sclerosis, Multiple sclerosis, Myasthenia Gravis, Lambert-Eaton syndrome, others per PI's discretion)
• Active infection in treatment area
• Active moderate or severe inflammatory disease in treatment area such as atopic dermatitis, psoriasis
• Prior treatment with neuromodulators in treatment area (neck) within the past 6 months

Sponsors & Collaborators

• Main Line Center for Laser Surgery: lead

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Study Officials

• Kachiu Lee, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 26, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 5 years
• Access Criteria: IRB approval

Locations

US (1)